Model Number 02.07.0005 |
Device Problem
Difficult to Remove (1528)
|
Patient Problem
No Code Available (3191)
|
Event Date 05/25/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Batch review performed by regulatory affairs department on 3 june 2020: lot 145743a: (b)(4) items manufactured and released on 11 october 2019.Expiration date: 2024-09-24.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold without any similar reported event.Other device involved in the event: gmk hinge 02.07.10.9641 offset adapter 5mm lot 1856269.Batch review performed by medacta regulatory affairs department on 24 june 2020: lot 1856269: (b)(4) items manufactured and released on 16 january 2019.No anomalies found related to the problem.To date, no similar events reported on items of the same lot.
|
|
Event Description
|
When trying to assemble the offset onto the tibia, the offset does not come out of the instrument (offset adaptor), it stays in there and doesn't connect to the tibia.This has happened a few times and following the surgical technique correctly.Due to this case additional anesthesia was necessary and the surgery was prolonged of 10 minutes.
|
|
Manufacturer Narrative
|
Visual inspection performed by medacta r&d knee project manager: during the visual inspection to the internal o-ring and the three fixation teeth have been found damaged.However, these damages cannot be related to the failure of the implant offset insertion, whose cause remains unknown.Since we do not have the 5 mm implant offset available for evaluation and, since the 5 mm trial offset can be properly connected, we can not establish the real cause of the failure during the surgery.(the internal profile and surfaces of the offset connector and there are no visible signs of wear).
|
|
Search Alerts/Recalls
|